Effect of Ketone Esters on Liver Fat and Metabolic Function in Adolescents and Young Adults With Overweight/Obesity and MASLD
Washington University School of Medicine
Summary
The goal of this clinical trial is to determine whether ingestion of a ketone ester drink helps improve liver health and blood glucose control. Ketones are a type of energy source made by the body during times of weight loss, low carbohydrate intake and starvation. People enrolled in this study will be randomly assigned (by chance, like the flip of a coin) to one of two groups: Group 1: Ketone ester drink consumed daily for 6 weeks. Group 2: Placebo drink consumed daily for 6 weeks.
Description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common complication of obesity and is associated with multiorgan insulin resistance, dyslipidemia (high plasma triglyceride and low HDL cholesterol concentrations), and an increased risk of diabetes and coronary heart disease. The prevalence of MASLD continues to rise dramatically in children and adolescents, with approximately 13 to 19% of adolescents and young adults in the United States estimated to have hepatic steatosis (elevated amount of fat in the liver), the hallmark feature of MASLD. Evidence is emerging that incre…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age: ≥18 and ≤40 years; * BMI 25.0 - 49.9 kg/m2; * Intrahepatic triglyceride content \>5% assessed by using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Exclusion Criteria: * HbA1C ≥6.5%; * taking dietary supplements or medications known to affect our study outcomes including corticosteroids and other drugs associated with steatosis (metformin use will be allowable if participants have taken a stable dose for at least 3 months without any gastrointestinal-related symptoms); * active eating disorder, any anaphylactic food allergy and/or consuming a…
Interventions
- Drugbis-octanoyl (R)-1,3-butanediol (C8 ketone di-ester)
25 g C8 ketone di-ester taken daily for approximately 6-weeks
- OtherPlacebo
25 g Placebo taken daily for approximately 6-weeks
Location
- Washington University School of MedicineSt Louis, Missouri